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The Food and Drug Administration (FDA) in America has granted fast track designation to ADI-270 for the treatment of patients with metastatic or advanced kidney cancer who received prior treatment with immunotherapy and a targeted therapy (tyrosine kinase inhibitor or TKI).
ADI-270 is an off-the-shelf chimeric antigen receptor (CAR) T cell therapy. CAR T cell therapies, which are popular for the treatment of certain blood cancers, are a type of immunotherapy that changes T cells so they are able to recognise and attack cancer cells. Traditionally, CAR-T cell therapies use a patient’s own T cells, but off-the-shelf products use the T cells of healthy donors.
T cells are immune system cells that play several key roles in the body’s fight against disease. They help the immune system respond to disease and they attack and kill abnormal cells. Unfortunately, naturally occurring T cells in patients with cancer are not good at recognising and fighting cancer cells.
Results from a study in America have shown that more than 80% of patients with advanced kidney cancer benefited from CAR T cell therapy. Three quarters of patients had stable disease and one patient (of 16 patients in the study) had a long lasting complete response to treatment of more than three years during which time they were cancer-free. Based on these positive findings, the researchers are currently enrolling patients in a phase I/II clinical trial to evaluate CAR T cell therapy in metastatic or advanced kidney cancer.
The fast track designation is meant to speed up the development and review of drugs that fill an unmet need in the USA. However, the FDA’s decisions also impact the decisions of regulatory authorities in Europe.
